A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites

Ischemic Stroke Clinical Trial

— GCNKSS  

Official title:

A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites: A Population-Based Study in Cincinnati, Ohio

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00642213
• Other study ID #: UC IRB 2013-3959
• Secondary ID: R01NS030678
• Status: Active, not recruiting
• Start date: July 1993
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Our primary goal is to study temporal trends in the incidence rate, causes, treatment, and outcome of stroke among a large biracial metropolitan population of 1,349,351, of whom 215,611 (15%) are black (2000 Census). Such data are critical for the planning, intervention, and evaluation of public health efforts to decrease the mortality and morbidity due to stroke in the United States.

We have completed this goal for 1993-94, 1999, 2005, 2010 and 2015. We are in the process of collecting this data for 2020. In the 2020 study period we will also be ascertaining 3 year recurrence rates for all incident stroke events.

Description:

For calendar years 1993-94, 1999, 2005, 2010, 2015, and 2020 we will or have identified every hospitalized or autopsied stroke and transient ischemic attack (TIA) at all regional hospitals in our region. We will also estimate the number of non-hospitalized strokes and TIAs by screening for potential cases at more than 100 outpatient sites throughout five counties in Greater Cincinnati/Northern Kentucky. We plan to identify and abstract detailed information from the medical record for every potential case. These results will be compared with data from all stroke patients identified by similar methodology in all study periods.

In addition, we have interviewed 1500 ischemic stroke patients and/or their families in the study periods 1999-2010 to obtain detailed information including demographic information, functional outcome and quality of life, access to and type of rehabilitation therapy, social support, caregiver availability and health status, access to post-hospital care, health insurance status, current health status, medications, prior risk factors, and knowledge about stroke signs and symptoms. We also obtained genetic material via a blood sample for most of this cohort.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ischemic stroke

• occurred in 1999/2005/2010

• >18 years old

• resides in 5 county region

Exclusion Criteria:

• <18 years old

• resides outside 5 county region

• inability to consent or have legal proxy consent

Related Conditions & MeSH terms

• Cerebral Infarction
• Hemorrhage
• Ischemia
• Ischemic Stroke
• Stroke
• TIA

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	2020 Stroke population mRS	we will collect 3 months, 6 months, and 1 year mRS outcomes on the 2020 stroke patients	3 month, 6 month, and 1 year
Primary	mRS	modified Rankin Scale	discharge or 30 days
Secondary	mortality	entire patient population checked for possible death record via NDI/CDC	1 year